Clinical trial · Interventional
Fulvestrant in Treating Patients With Recurrent Prostate Cancer
Multicenter Study of Fulvestrant (Faslodex®) in Early, Recurrent Prostate Cancer Following Local Therapy: A Phase II Trial
NCT00217464CI-TRIAL-00017556terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed for futility
Summary
Brief summary (as posted)
RATIONALE: Estrogen may cause the growth of prostate cancer cells. Hormone therapy using fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells. PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with recurrent prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fulvestrant
- description
- Fulvestrant will be provided as 250 mg in 5 mL as a pre-tilled syringe. Fulvestrant will be administered as 500 mg, that is, 2 injections of 5 mL, one into each buttock im on day 0. A single 250 mg in 5 mL injection will be administered on day 14 followed by a single 250 mg in 5 mL dose on day 28 and monthly thereafter.
- interventionNames
- Drug: fulvestrant
Primary outcomes (1)
- measure
- Proportion of Patients Who Respond to Treatment.
- timeFrame
- 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment
- description
- Response is defined to be the clear slowing of the rate of increase of PSA levels with time
Secondary outcomes (1)
- measure
- Number of Participants With Progressive Disease at Day +90
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Early recurrent disease, defined by 1 of the following criteria:
* Prostate-specific antigen (PSA) ≥ 2.0 ng/mL AND clearly rising within the past 3 months for patients who underwent prior prostatectomy with or without radiotherapy
* PSA ≥ 4.0 ng/mL AND clearly rising from the lowest value obtained within the past 6 months for patients who underwent prior definitive radiotherapy only
* No evidence of clinical recurrence,\* as defined by the following criteria:
* Digital rectal exam negative
* No local recurrence by CT scan or MRI of the pelvis
* No evidence of bone metastasis by bone scan NOTE: \*Prostascint scan results are not considered evidence of recurrence
* Underwent prior curative treatment comprising radical prostatectomy with or without adjuvant radiotherapy OR definitive radiotherapy alone
* Testosterone (total or free) \> than lower limit of normal
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC \> 3,500/mm\^3
* Platelet count \> 100,000/mm\^3
* No history of bleeding diathesis
Hepatic
* INR \< 1.6
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT or AST ≤ 2.5 times ULN
* No severe hepatic impairment that would preclude study participation or compliance
Renal
* Creatinine ≤ 2.0 mg/dL
* No severe renal impairment that would preclude study participation or compliance
Cardiovascular
* No unstable or uncompensated cardiac condition that would preclude study participation or compliance
Pulmonary
* No unstable or uncompensated respiratory condition that would preclude study participation or compliance
Other
* No history of hypersensitivity to active or inactive excipients of fulvestrant (e.g., castor oil)
* No other severe condition that would preclude study compliance (e.g., abuse of alcohol or drugs or psychotic states) or participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* More than 6 months since prior neoadjuvant or adjuvant androgen deprivation therapy or luteinizing hormone-releasing hormone antagonist therapy
* No other prior or concurrent hormonal therapy
Radiotherapy
* See Disease Characteristics
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
Other
* More than 4 weeks since prior experimental drug treatment
* No concurrent anticoagulant therapy except antiplatelet therapy
* No other concurrent therapy for prostate cancer
* No other concurrent therapy known or suspected of altering androgen metabolism or androgen levelsReferences
Publications (0)
Data not yet available
No reference posted for this study.